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Gynecare Intergel Recall

En EspaƱol [GYNECARE INTERGEL]

gynecare_intergelIn April, 2003, Gynecare Worldwide, a division of Ethicon, Inc., the product distributor, issued a voluntary withdrawal of Gynecare Intergel Adhesion Prevention Solution and advised that customers immediately stop using the product. Gynecare received reports of post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence.

The product, manufactured by Lifecore Biomedical, Inc. and marketed by Johnson & Johnson's Gynecare unit, was used from 1998 to the recall date to help reduce post-operative internal scarring that led to intestinal obstruction and chronic pain. It has also been used "off-label" in laparoscopy and other surgical procedures such as hysterectomy.

Some history of Gynecare Intergel

The Food and Drug Administration (FDA) approved Intergel in November 2001 as an anti-adhesion surgical gel for gynecological surgeries, but the agency originally refused to approve the product, determining that the gel actually increased a woman's risk of infections. The manufacturer appealed the denial and the FDA reevaluated its decision: the appeal commission reversed the FDA's initial denial and approved the adhesive, but only as "reasonably safe." According to the FDA, 5.6% of those who received the gel developed an infection at the surgical site compared to only 2.9% of women who received more conventional treatment.

The manufacturer of Gynecare Intergel Adhesion Prevention Solution is currently assessing technical issues, surgical techniques and circumstances associated with these post-market events.

If you have experienced health problems because of Intergel, see your doctor. You may also want to contact a lawyer who can help protect your legal rights. Please keep in mind that there may be a statute of limitations - act now rather than later.


Articles about Gynecare Intergel

Gynecare Intergel: Why was it Approved?
Recent headlines announcing the reinstatement of still-worrisome drugs is an eerie reminder of what happened when Gynecare Intergel Adhesion Prevention Solution was initially considered by the U.S. Food and Drug Administration (FDA). Voluntarily pulled from the market by Johnson&Johnson (an Ethicon company) in 2003, Intergel has since been at the centre of numerous lawsuits.

Intergel Scandal: A "Dangerous Precedent" at FDA?
In the wake of the Gynecare Intergel recall, many critics are questioning why the Food and Drug Administration (FDA) ever approved Intergel for medical use. Could it be, as some suggest, that the FDA is playing politics to its drug-company funders?

Off-Label Use Sinks Gynecare Intergel
The Short, Unhappy History of Intergel
Gynecare: A Red Flag Ignored
Gynecare Intergel: More Lawsuits Pending?
Gynecare Intergel Linked To Pain, Tissue Adherence, and Internal Scarring


Gynecare Intergel Legal Help

If you or a loved one has suffered from the use of Gynecare Intergel Adhesion Prevention Solution, you may qualify for damages or remedies that may be awarded in a possible class action or lawsuit. Please fill in our form on the right to send your complaint to a lawyer for a free evaluation.
Last updated August 20 2012

Reader Comments


Posted by

on
I was almost dead from this stuff. Was put in icu. I've never Ben the same. They used it in a laperoscopy for adhesions. On Nov 1 2002. I have been raising my grandsons and have had 2 cancers. No immune system been on infusions for immune system etc. Been in pain, amazing pain. Grateful to be alive. I smile everyday!! I don't understand why it was used. Sadly it was questioned the day before, it was contaminated.
Was a terrible thing, again grateful to be alive

Posted by

on
Currently, I am UNABLE to work due to severe abdominal/pelvic adhesions. I am affraid of an additional surgery (as research indicates once the adhesions are removed, they along with additional ahesions will come back) but I cannot even function on pain medication. PLEASE HELP ME!!!

Posted by

on
After the hysterectomy I got a vaginal wall infection plus a urinary tract infection which caused blood in urine for over 2 weeks also I had trouble healing at the sites of where the incisions were made.

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